study to evaluate armodafinil treatment in improving prefrontal cortical activation and working memory performance

Conditions: Excessive Sleepiness

Summary: the primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with osahs (obstructive sleep apnea/hypopnea syndrome) who have residual sleepiness despite receiving ncpap therapy.


Eligibility criteria:
inclusion criteria: * patient has a current diagnosis of osahs and has a complaint of excessive sleepiness despite effective ncpap therapy. * patient has excessive sleepiness as evidenced by a mean sleep latency of less than 8 minutes, as determined by the mslt. * patient has an ess score of 10 or more at the initial screening visit. * patient has a habitual sleep time beginning no earlier than 2100 and ending no later than 0700. * patient is right-handed. patients who are ambidextrous may be eligible following consultation with the medical monitor. * women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. * patient exhibits reasonable accuracy (≥80%) on the 2-back working memory task during the training session at the second screening visit. exclusion criteria: the patient: * the patient is a current smoker or has a prior history of smoking (defined as ≥1 pack-year) within 2 years prior to the screening visit. * consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 400 mg of caffeine per day (approximately equivalent to 4 or more cups of coffee). * has nart-predicted verbal iq and qids-sr16 scores within protocol-specific exclusionary ranges. * has a clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated). * has a confirmed or probable diagnosis of a current sleep disorder other than osahs. * has used any excluded prescription drugs or procedures for prohibited and allowed drugs within the excluded timeframe. * has a history of alcohol, narcotic, or any other drug abuse. * has a positive uds, without medical explanation, at the screening visit. * has a clinically significant deviation from normal in the physical examination. * is a pregnant or lactating woman. any woman becoming pregnant during the study will be withdrawn from the study. * has a past or present seizure disorder, head trauma that is clinically significant, or past neurosurgery. * has used an investigational drug within 1 month before the screening visit. * has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery). * has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets. * has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions. * has known human immunodeficiency virus (hiv). * has clinical laboratory test value(s) outside the range(s) specified in the protocol, or presents a clinically significant laboratory abnormality without prior written approval by the medical monitor. * has worked the night shift within 28 days of the baseline visit, or will work the night shift during the double-blind segment of the study. * anticipates any travel across more than 3 time zones at any time during the study. * needs to use any of the excluded medications identified in this protocol. * is unable to complete neuroimaging studies, performance tasks, self-rating scales, and all other study assessments. * has a contraindication to fmri scanning, (such as an implanted pacemaker/defibrillator, aneurysm clips, drug infusion device or metallic foreign body). * is suspected to be unable to tolerate fmri scanning (eg, claustrophobic) and/or the testing paradigm. * has physical or other characteristics that suggest imaging data will be unobtainable or degraded.